Thrombus removal systems and devices and methods of using the same

ABSTRACT

Thrombectomy systems and devices and methods of using the same. In an exemplary embodiment of a thrombectomy system of the present disclosure, the thrombectomy system comprises a thrombectomy sheath, comprising a circumferential outer wall reinforced with a reinforcement, configured as an elongated tube having a lumen therethrough; and a sonovisible element positioned at or near a distal end of the circumferential outer wall; wherein the thrombectomy sheath is sized and shaped to be at least partially positioned within a vein proximal to a thrombus or other item within the vein and further configured to expand to contact the vein to secure the thrombectomy sheath within the vein; and wherein the lumen is sized and shaped to receive a device selected from the group consisting of a balloon catheter and a snare having a loop.

PRIORITY

The present application a) is related to, and claims the prioritybenefit of, U.S. Provisional Patent Application Ser. No. 62/199,203,filed Jul. 30, 2015, and b) is related to, claims the priority benefitof, and is a U.S. continuation-in-part patent application of, U.S.Nonprovisional patent application Ser. No. 13/491,754, filed Jun. 8,2012, which is related to, and claims the priority benefit of, U.S.Provisional Patent Application Ser. No. 61/494,561, filed Jun. 8, 2011.The contents of each of the aforementioned patent applications areincorporated by reference in their entirety into this disclosure.

BACKGROUND

Thrombogenesis, which involves the localized accumulation of bloodelements on an injured vessel wall, can cause heart attacks and strokes.Although a thrombus is initially composed of platelets and fibrin thatserve to limit bleeding, excessive thrombus growth can lead tothrombosis that obstructs blood vessels and hence can produce ischemiain vascular beds.

Current options for venous thrombectomy are limited. Of the two deviceswidely used currently, one has been recently withdrawn and the other(Angiojet™) is known to produce side effects such as hemoglobinuria,renal failure and pancreatitis in patients. Furthermore, the smallcatheter size is limiting its usefulness in extensive thrombosis; fluidoverload is a concern as saline has to be injected to pulverize the clotdrawn into the catheter.

In patients at risk of thrombosis, conventional drug treatments (such asaspirin, heparin, and warfarin, for example) are used to slow thrombusgrowth. However, such treatments have the risk of bleeding complicationsthat can be serious and sometimes fatal. For patients that develop athrombus, there are approaches known in the art for retrieval of thethrombus (such as catheters and balloons) as well as chemical approachesto dissolve the thrombus (such as tissue plasminogen activators orplasmin). The chemicals, however, are not localized to the thrombus andcan circulate through the patient's blood and cause bleeding. Hence,there is a need for localization of thrombus dissolution eitherchemically or physically and its removal without affecting the rest ofthe cardiovascular system.

BRIEF SUMMARY

The disclosure of the present application provides various thrombusremoval systems and devices and methods of using the same.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the thrombus removal system comprises an umbrella cathetercomprising an umbrella catheter tube and an umbrella positioned at leastpartially within the umbrella catheter tube when in a compressedconfiguration and positioned external to the umbrella catheter tube whenin a deployed configuration, and a balloon catheter configured to fitaround at least part of the umbrella catheter, the balloon cathetercomprising a balloon catheter tube and a balloon coupled thereto, theballoon capable of inflation within a lumen of a mammalian vessel tosubstantially or completely occlude the lumen of the mammalian vessel,the thrombus removal system configured to disrupt and/or dissolve andremove at least a portion of a thrombus positioned within the lumen ofthe mammalian vessel. In another embodiment, at least part of theumbrella catheter is configured to fit around a guidewire. In yetanother embodiment, the system further comprises a guidewire having adistal end, the guidewire configured to puncture the thrombus andfurther configured to allow at least part of the umbrella catheter tofit around the guidewire. In an additional embodiment, the umbrella isconfigured to at least substantially occlude the lumen of the mammalianvessel when in the deployed configuration.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, wherein the umbrella is configured to at allow fluid to passtherethrough but prevent at least a portion of the thrombus from passingtherethrough when in the deployed configuration. In an additionalembodiment, the system is configured to introduce one or more chemicalagents into the lumen of the mammalian vessel, the one or more chemicalagents capable of disrupting and/or dissolving at least a portion of thethrombus. In yet an additional embodiment, the one or more chemicalagents are selected from the group consisting of a tissue plasminogenactivator, plasmin and thrombin.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the balloon catheter tube further defines one or moreapertures therein, the one or more apertures configured to allow a fluidand/or a substance to pass therethrough from a first balloon catheterlumen defined within the balloon catheter tube. In another embodiment,the balloon catheter tube is configured so that one or more chemicalagents can be introduced through the first balloon catheter lumen,through the one or more apertures, and into the lumen of the mammalianvessel. In another embodiment, the balloon catheter tube further definesa distal tube aperture in communication with a second balloon catheterlumen, wherein a fluid and/or a substance from within the lumen of themammalian vessel can enter second balloon catheter lumen through thedistal tube aperture when suction is applied through the second ballooncatheter lumen. In an additional embodiment, the balloon catheter tubefurther defines a distal tube aperture in communication with a secondballoon catheter lumen, wherein at least a portion of the thrombus fromwithin the lumen of the mammalian vessel can enter second ballooncatheter lumen through the distal tube aperture when suction is appliedthrough the second balloon catheter lumen to remove at least a portionof the thrombus. In yet an additional embodiment, the balloon cathetertube is configured so that a fluid can be introduced through the firstballoon catheter lumen, through the one or more apertures, and into thelumen of the mammalian vessel to flush the lumen of the mammalianvessel.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the system is configured to introduce one or more disruptiveoscillations into the lumen of the mammalian vessel, the one or moredisruptive oscillations capable of disrupting at least a portion of thethrombus. In an additional embodiment, the one or more disruptiveoscillations are introduced via ultrasound through one or more of theballoon catheter and the umbrella catheter. In yet an additionalembodiment, the balloon is capable of inflation and deflation by way ofan inflation/deflation lumen defined within the balloon catheter tube.In another embodiment, the system further comprises aninflation/deflation source in communication with the inflation/deflationlumen, the inflation/deflation source capable of inflating and/ordeflating balloon by way of a gas and/or a liquid from theinflation/deflation source.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the system further comprises a substance source incommunication with a first balloon catheter lumen defined within theballoon catheter tube, the substance source capable of introducing oneor more chemical agents and/or or a fluid from the substance source,through the first balloon catheter lumen, through one or more aperturesdefined within the balloon catheter tube, and into the lumen of themammalian vessel. In an additional embodiment, the system furthercomprises a suction source in communication with a second ballooncatheter lumen defined within the balloon catheter tube, the suctionsource capable of removing fluid and/or a particulate from the lumen ofthe mammalian vessel during operation of the suction source.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the system comprises a guidewire having a distal end, theguidewire configured to puncture a thrombus positioned within a lumen ofa mammalian vessel, an umbrella catheter configured to fit around atleast part of the guidewire, the umbrella catheter comprising anumbrella catheter tube and an umbrella positioned at least partiallywithin the umbrella catheter tube when in a compressed configuration andpositioned external to the umbrella catheter tube when in a deployedconfiguration, a balloon catheter configured to fit around at least partof the umbrella catheter, the balloon catheter comprising a ballooncatheter tube and a balloon coupled thereto, the balloon capable ofinflation within a lumen of a mammalian vessel to substantially orcompletely occlude the lumen of the mammalian vessel, the ballooncatheter defining a first lumen, a second lumen, and a third lumentherethrough, the first lumen in communication with one or moreapertures defined within the balloon catheter tube, the second lumen incommunication with a distal tube aperture, and the third lumen incommunication with the balloon, the thrombus removal system configuredto disrupt and/or dissolve and remove at least a portion of the thrombusfrom within the lumen of the mammalian vessel by way introducing one ormore chemical agents and/or one or more disruptive oscillations into thelumen of the vessel, the one or more chemical agents and/or one or moredisruptive oscillations capable of disrupting and/or dissolving at leasta portion of the thrombus.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the system comprises a balloon catheter optionallyconfigured to fit around at least part of an umbrella catheter, theballoon catheter comprising a balloon catheter tube and a first balloonand a second balloon coupled thereto, the first balloon and the secondballoon capable of inflation within a lumen of a mammalian vessel tosubstantially or completely occlude the lumen of the mammalian vessel,the thrombus removal system configured to disrupt and/or dissolve andremove at least a portion of a thrombus positioned within the lumen ofthe mammalian vessel. In another embodiment, at least part of theumbrella catheter is configured to fit around a guidewire. In anotherembodiment, the system further comprises a guidewire having a distalend, the guidewire configured to puncture the thrombus and furtherconfigured to allow at least part of the balloon catheter to fit aroundthe guidewire.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the system is configured to introduce one or more chemicalagents into the lumen of the mammalian vessel, the one or more chemicalagents capable of disrupting and/or dissolving at least a portion of thethrombus. In an additional embodiment, the one or more chemical agentsare selected from the group consisting of a tissue plasminogenactivator, plasmin and thrombin. In yet an additional embodiment, theballoon catheter tube further defines one or more apertures therein, theone or more apertures configured to allow a fluid and/or a substance topass therethrough from a first balloon catheter lumen defined within theballoon catheter tube. In another embodiment, the balloon catheter tubeis configured so that one or more chemical agents can be introducedthrough the first balloon catheter lumen, through the one or moreapertures, and into the lumen of the mammalian vessel.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the balloon catheter tube further defines a removal aperturein communication with a second balloon catheter lumen, wherein a fluidand/or a substance from within the lumen of the mammalian vessel canenter second balloon catheter lumen through the removal aperture whensuction is applied through the second balloon catheter lumen. In anotherembodiment, the balloon catheter tube further defines a removal aperturein communication with a second balloon catheter lumen, wherein at leasta portion of the thrombus from within the lumen of the mammalian vesselcan enter second balloon catheter lumen through the removal aperturewhen suction is applied through the second balloon catheter lumen toremove at least a portion of the thrombus. In yet another embodiment,the balloon catheter tube is configured so that a fluid can beintroduced through the first balloon catheter lumen, through the one ormore apertures, and into the lumen of the mammalian vessel to flush thelumen of the mammalian vessel. In an additional embodiment, the systemis configured to introduce one or more disruptive oscillations into thelumen of the mammalian vessel, the one or more disruptive oscillationscapable of disrupting at least a portion of the thrombus. In yet anadditional embodiment, the one or more disruptive oscillations areintroduced via ultrasound through the balloon catheter.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the first balloon and the second balloon are capable ofinflation and deflation by way of at least one inflation/deflation lumendefined within the balloon catheter tube. In an additional embodiment,the system further comprises an inflation/deflation source incommunication with the at least one inflation/deflation lumen, theinflation/deflation source capable of inflating and/or deflating thefirst balloon and the second balloon by way of a gas and/or a liquidfrom the inflation/deflation source. In yet an additional embodiment,the system further comprises a substance source in communication with afirst balloon catheter lumen defined within the balloon catheter tube,the substance source capable of introducing one or more chemical agentsand/or or a fluid from the substance source, through the first ballooncatheter lumen, through one or more apertures defined within the ballooncatheter tube, and into the lumen of the mammalian vessel. In anotherembodiment, the system further comprises a suction source incommunication with a second balloon catheter lumen defined within theballoon catheter tube, the suction source capable of removing fluidand/or a particulate

In an exemplary embodiment of a method of removing a thrombus from alumen of a mammalian vessel of the present disclosure, the methodcomprises the steps of inserting a guidewire into a lumen of a mammalianvessel through a thrombus present therein, inserting an umbrellacatheter through the thrombus around at least part of the guidewire,inserting a balloon catheter through the thrombus around at least partof the umbrella catheter, deploying an umbrella of the umbrella catheterto at least substantially occlude the lumen of the mammalian vesseldistal to the thrombus or to at least substantially prevent a portion ofthe thrombus from passing through the umbrella, inflating a balloon ofthe balloon catheter to at least substantially occlude the lumen of themammalian vessel proximal to the thrombus, operating one or more of theumbrella catheter and/or the balloon catheter to disrupt and/or dissolvethe thrombus, and applying suction through the balloon catheter toremove at least part of the disrupted thrombus from the lumen of themammalian vessel. In another embodiment, the step of operating one ormore of the umbrella catheter and/or the balloon catheter comprisesintroducing one or more chemical agents through the balloon catheterinto the lumen of the mammalian vessel to disrupt and/or dissolve thethrombus. In yet another embodiment, the step of operating one or moreof the umbrella catheter and/or the balloon catheter comprisesintroducing one or more disruptive oscillations therethrough to disruptthe thrombus. In an additional embodiment, the method further comprisesthe steps of deflating the balloon and inverting the umbrella so thatthe umbrella can be positioned at least partially within a distalaperture of the balloon catheter, and removing the guidewire, theumbrella catheter, and the balloon catheter from the lumen of themammalian vessel.

In an exemplary embodiment of a method of removing a thrombus from alumen of a mammalian vessel of the present disclosure, the methodcomprises the steps of inserting a guidewire into a lumen of a mammalianvessel through a thrombus present therein, inserting a balloon catheterthrough the thrombus around at least part of the guidewire, inflating afirst balloon of the balloon catheter to at least substantially occludethe lumen of the mammalian vessel proximal to the thrombus and inflatinga second balloon of the balloon catheter to at least substantiallyocclude the lumen of the mammalian vessel distal to the thrombus,operating the balloon catheter to disrupt and/or dissolve the thrombus,and applying suction through the balloon catheter to remove at leastpart of the disrupted thrombus from the lumen of the mammalian vessel.In another embodiment, the step of operating the balloon cathetercomprises introducing one or more chemical agents through the ballooncatheter into the lumen of the mammalian vessel to disrupt and/ordissolve the thrombus. In another embodiment, the step of operating theballoon catheter comprises introducing one or more disruptiveoscillations therethrough to disrupt the thrombus. In an additionalembodiment, the method further comprises the steps of deflating thefirst balloon and the second balloon, and removing the guidewire and theballoon catheter from the lumen of the mammalian vessel.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the thrombus removal system comprises a balloon cathetercomprising a balloon catheter tube and a first balloon coupled thereto,the first balloon capable of inflation within a lumen of a mammalianvessel to substantially or completely occlude the lumen of the mammalianvessel, and a second occlusion element configured to at leastsubstantially occlude the lumen of the mammalian vessel, wherein thethrombus removal system is configured to disrupt and/or dissolve andremove at least a portion of a thrombus positioned within the lumen ofthe mammalian vessel. In another embodiment, the second occlusionelement comprises an umbrella catheter comprising an umbrella cathetertube and an umbrella positioned at least partially within the umbrellacatheter tube when in a compressed configuration and positioned externalto the umbrella catheter tube when in a deployed configuration, whereinthe umbrella is configured to at least substantially occlude the lumenof the mammalian vessel when in the deployed configuration, and whereinthe balloon catheter is configured to fit around at least part of theumbrella catheter. In yet another embodiment, the thrombus removalsystem further comprises a guidewire having a distal end, the guidewireconfigured to puncture the thrombus, wherein at least part of theumbrella catheter is configured to fit around the guidewire. In anadditional embodiment, the umbrella is configured to at allow fluid topass therethrough but prevent at least a portion of the thrombus frompassing therethrough when in the deployed configuration. In an exemplaryembodiment of a thrombus removal system of the present disclosure, whenthe first balloon is positioned proximal to the thrombus and inflated toat least substantially occlude the lumen of the mammalian vessel andwherein when the umbrella is positioned distal to the thrombus andoperated to at least substantially occlude the lumen of the mammalianvessel, operation of one or more of the umbrella catheter and/or theballoon catheter can disrupt and/or dissolve the thrombus, and use ofsuction through the balloon catheter can facilitate removal of at leastpart of the disrupted thrombus from the lumen of the mammalian vessel.In an additional embodiment, the first balloon is capable of inflationand deflation by way of an inflation/deflation lumen defined within theballoon catheter tube.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the second occlusion element comprises a second ballooncoupled to the balloon catheter tube, the second balloon capable ofinflation within the lumen of the mammalian vessel to substantially orcompletely occlude the lumen of the mammalian vessel, and wherein thefirst balloon and the second balloon are capable of inflation anddeflation by way of at least one inflation/deflation lumen definedwithin the balloon catheter tube. In another embodiment, when the firstballoon is positioned proximal to the thrombus and inflated to at leastsubstantially occlude the lumen of the mammalian vessel and wherein whenthe second balloon is positioned distal to the thrombus and inflated toat least substantially occlude the lumen of the mammalian vessel,operation of the balloon catheter can disrupt and/or dissolve thethrombus, and use of suction through the balloon catheter can facilitateremoval of at least part of the disrupted thrombus from the lumen of themammalian vessel. In yet another embodiment, the system is configured tointroduce one or more chemical agents into the lumen of the mammalianvessel, the one or more chemical agents capable of disrupting and/ordissolving at least a portion of the thrombus. In an additionalembodiment, the balloon catheter tube further defines one or moreapertures therein, the one or more apertures configured to allow a fluidand/or a substance to pass therethrough from a first balloon catheterlumen defined within the balloon catheter tube. In yet an additionalembodiment, the balloon catheter tube further defines a distal tubeaperture in communication with a second balloon catheter lumen, whereinat least a portion of the thrombus from within the lumen of themammalian vessel can enter second balloon catheter lumen through thedistal tube aperture when suction is applied through the second ballooncatheter lumen to remove at least a portion of the thrombus.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the balloon catheter tube is configured so that a fluid canbe introduced through the first balloon catheter lumen, through the oneor more apertures, and into the lumen of the mammalian vessel to flushthe lumen of the mammalian vessel. In an additional embodiment, thesystem is configured to introduce one or more disruptive oscillationsthrough one or more of the balloon catheter and a portion of the secondocclusion element and into the lumen of the mammalian vessel, whereinthe one or more disruptive oscillations capable of disrupting at least aportion of the thrombus. In yet an additional embodiment, the thrombusremoval system further comprises a substance source in communicationwith a first balloon catheter lumen defined within the balloon cathetertube, the substance source capable of introducing one or more chemicalagents and/or or a fluid from the substance source, through the firstballoon catheter lumen, through one or more apertures defined within theballoon catheter tube, and into the lumen of the mammalian vessel. Inanother embodiment, the thrombus removal system further comprises asuction source in communication with a second balloon catheter lumendefined within the balloon catheter tube, the suction source capable ofremoving fluid and/or a particulate from the lumen of the mammalianvessel during operation of the suction source.

In an exemplary embodiment of a thrombus removal system of the presentdisclosure, the thrombus removal system comprises a guidewire having adistal end, the guidewire configured to puncture a thrombus positionedwithin a lumen of a mammalian vessel, a balloon catheter comprising aballoon catheter tube and a first balloon coupled thereto, the firstballoon capable of inflation within a lumen of a mammalian vessel tosubstantially or completely occlude the lumen of the mammalian vessel,and a second occlusion element configured to at least substantiallyocclude the lumen of the mammalian vessel, the second occlusion elementselected from the group consisting of (i) an umbrella cathetercomprising an umbrella catheter tube and an umbrella positioned at leastpartially within the umbrella catheter tube when in a compressedconfiguration and positioned external to the umbrella catheter tube whenin a deployed configuration, wherein the umbrella is configured to atleast substantially occlude the lumen of the mammalian vessel when inthe deployed configuration, and (ii) a second balloon coupled to theballoon catheter tube, the second balloon capable of inflation withinthe lumen of the mammalian vessel to substantially or completely occludethe lumen of the mammalian vessel, the thrombus removal systemconfigured to disrupt and/or dissolve and remove at least a portion ofthe thrombus from within the lumen of the mammalian vessel by wayintroducing one or more chemical agents and/or one or more disruptiveoscillations into the lumen of the vessel, the one or more chemicalagents and/or one or more disruptive oscillations capable of disruptingand/or dissolving at least a portion of the thrombus.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system comprises a thrombectomy sheath,comprising a circumferential outer wall reinforced with a reinforcement,configured as an elongated tube having a lumen therethrough; and asonovisible element positioned at or near a distal end of thecircumferential outer wall; wherein the thrombectomy sheath is sized andshaped to be at least partially positioned within a vein proximal to athrombus or other item within the vein and further configured to expandto contact the vein to secure the thrombectomy sheath within the vein;and wherein the lumen is sized and shaped to receive a device selectedfrom the group consisting of a balloon catheter and a snare having aloop.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the circumferential outer wall comprises a flexible polymermaterial, and wherein the reinforcement comprises a metallic material.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the circumferential outer wall is configured forautoexpansion.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system further comprises a balloonpositioned at or near a distal end of the circumferential outer wall, atleast partially positioned within an indention defined within thecircumferential outer wall.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system further comprises a first obturatorconfigured to fit within the lumen of the thrombectomy sheath, the firstobturator comprising a flange configured to engage a proximal coupler ofthe thrombectomy sheath and defining a tapered portion at a distal end,the tapered portion configured to extend from the distal end of thethrombectomy sheath so to dilate the vein when advanced therein.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system further comprises a second obturatorcomprising an elongated portion and a cylindrical portion having alarger diameter than the elongated portion, the cylindrical portionhaving a hemi-cylindrical groove defined therein configured to receiveat least part of the balloon catheter, and further comprising a fittingring configured to fit upon the cylindrical portion and rotate thereonso to lock at least part of the balloon catheter within the cylindricalgroove.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system further comprises a third obturatorcomprising a generally uniform cylinder having a flat tip, the thirdobturator configured to extend at least 2 cm from the distal end of thethrombectomy sheath when positioned therein.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system further comprises an ancillarydilator comprising an elongated portion and a relatively larger ovularportion having a pointed tip and defining a groove therein configured toreceive at least part of a balloon catheter therein, and furthercomprising a fitting ring configured to fit upon the relatively largerovular portion and rotate thereon so to lock at least part of theballoon catheter within the groove.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system further comprises the ballooncatheter.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system further comprises a hemostatic plugconfigured to be pushed through the lumen of the thrombectomy sheathusing the flat tip of the third obturator so that the hemostatic plug ispositioned within the vein after being pushed out of the thrombectomysheath.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system further comprises the snare having aloop, the snare configured to fit within the lumen of the thrombectomysheath and to engage a thrombus within the vein using the loop.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, when the thrombectomy sheath is at least partiallypositioned within the vein proximal to the thrombus, the ballooncatheter can be positioned through the lumen of the thrombectomy sheathso that a balloon of the balloon catheter is positioned distal to thethrombus, and whereby inflation of the balloon and retraction of theballoon catheter through the thrombectomy sheath removes the thrombusfrom the vein.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, when a guidewire is positioned within the vein and when thefirst obturator is positioned within the lumen of the thrombectomysheath, advancement of the first obturator and the thrombectomy sheathwithin the vein along the guidewire causes the vein to dilate.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system comprises a thrombectomy sheath,comprising a circumferential outer wall comprising a flexible polymermaterial reinforced with a reinforcement comprising a metallic material,configured as an elongated tube having a lumen therethrough; and asonovisible element positioned at or near a distal end of thecircumferential outer wall; wherein the thrombectomy sheath is sized andshaped to be at least partially positioned within a vein proximal to athrombus or other item within the vein and further configured to expandto contact the vein to secure the thrombectomy sheath within the vein;and wherein the lumen is sized and shaped to receive a device selectedfrom the group consisting of a balloon catheter and a snare having aloop; and a first obturator configured to fit within the lumen of thethrombectomy sheath, the first obturator comprising a flange configuredto engage a proximal coupler of the thrombectomy sheath and defining atapered portion at a distal end, the tapered portion configured toextend from the distal end of the thrombectomy sheath so to dilate thevein when advanced therein.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system further comprises a second obturatorcomprising an elongated portion and a cylindrical portion having alarger diameter than the elongated portion, the cylindrical portionhaving a hemi-cylindrical groove defined therein configured to receiveat least part of the balloon catheter, and further comprising a fittingring configured to fit upon the cylindrical portion and rotate thereonso to lock at least part of the balloon catheter within the cylindricalgroove.

In an exemplary embodiment of a thrombectomy system of the presentdisclosure, the thrombectomy system further comprises an ancillarydilator comprising an elongated portion and a relatively larger ovularportion having a pointed tip and defining a groove therein configured toreceive at least part of a balloon catheter therein, and furthercomprising a fitting ring configured to fit upon the relatively largerovular portion and rotate thereon so to lock at least part of theballoon catheter within the groove.

In an exemplary embodiment of a thrombectomy method of the presentdisclosure, the thrombectomy method comprises the steps of positioning adistal end of a thrombectomy sheath over a guidewire positioned within avein, the thrombectomy sheath comprising a circumferential outer wallreinforced with a reinforcement, configured as an elongated tube havinga lumen therethrough, and a sonovisible element positioned at or nearthe distal end of the circumferential outer wall, wherein thethrombectomy sheath is sized and shaped to be at least partiallypositioned within a vein proximal to a thrombus or other item within thevein and further configured to expand to contact the vein to secure thethrombectomy sheath within the vein, and wherein the lumen is sized andshaped to receive a device selected from the group consisting of aballoon catheter and a snare having a loop; advancing the thrombectomysheath having a first obturator positioned therein along the guidewireso to dilate the vein at the thrombectomy sheath; and advancing thedevice through the lumen of the thrombectomy sheath so that a distalelement of the device is positioned distal to the thrombus.

In an exemplary embodiment of a thrombectomy method of the presentdisclosure, the device comprises the balloon catheter, and wherein thestep of advancing the device is performed to advance the ballooncatheter through the lumen of the thrombectomy sheath so that a balloonof the balloon catheter is positioned distal to the thrombus; and themethod further comprises the steps of inflating the balloon within thevein distal to the thrombus; and retracting the balloon catheter throughthe thrombectomy sheath to remove the thrombus from the vein.

In an exemplary embodiment of a thrombectomy method of the presentdisclosure, the device comprises the snare having the loop, and whereinthe step of advancing the device is performed to advance the ballooncatheter through the lumen of the thrombectomy sheath so that the loopof the snare is positioned distal to the thrombus; and the methodfurther comprises the step of retracting the snare through thethrombectomy sheath to remove the thrombus from the vein.

In an exemplary embodiment of a thrombectomy method of the presentdisclosure, the method further comprises the step of positioning afilter distal to the thrombus within the vein, the filter configured tofilter blood within the vein.

BRIEF DESCRIPTION OF THE DRAWINGS

The above mentioned embodiments and other features, advantages anddisclosures contained herein, and the manner of attaining them, willbecome apparent and the present disclosure will be better understood byreference to the following description of various exemplary embodimentsof the present disclosure taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1A shows a mammalian vessel with a thrombus positioned therein,according to an embodiment of the present disclosure;

FIG. 1B shows at a guidewire positioned within a thrombus within amammalian vessel, according to an embodiment of the present disclosure;

FIG. 1C shows an umbrella catheter and a balloon catheter positionedwithin a thrombus within a mammalian vessel, according to an embodimentof the present disclosure;

FIGS. 1D and 2A show a deployed umbrella of the umbrella catheter shownin FIG. 1C, according to an embodiment of the present disclosure;

FIG. 2B shows the use of a chemical agent by way of a thrombus removalsystem within a mammalian vessel, according to an embodiment of thepresent disclosure;

FIG. 2C shows the disruption and/or dissolution of at least part of athrombus from the use of a chemical agent by way of a thrombus removalsystem within a mammalian vessel, according to an embodiment of thepresent disclosure;

FIG. 3A shows a deployed umbrella of the umbrella catheter shown in FIG.1C, according to an embodiment of the present disclosure;

FIG. 3B shows the use of disruptive oscillations by way of a thrombusremoval system within a mammalian vessel, according to an embodiment ofthe present disclosure;

FIG. 3C shows the disruption of at least part of a thrombus from the useof disruptive oscillations by way of a thrombus removal system within amammalian vessel, according to an embodiment of the present disclosure;

FIG. 4A shows portions of an exemplary thrombus removal systempositioned within a mammalian vessel with a partially deflated balloon,according to an embodiment of the present disclosure;

FIG. 4B shows portions of an exemplary thrombus removal systempositioned within a mammalian vessel with an inverted umbrella,according to an embodiment of the present disclosure;

FIG. 4C shows portions of an exemplary thrombus removal systempositioned within a mammalian vessel with some or all of the umbrellapositioned within the balloon catheter, according to an embodiment ofthe present disclosure;

FIG. 5 shows a block diagram of various components of an exemplarythrombus removal system, according to an embodiment of the presentdisclosure;

FIG. 6 shows steps of an exemplary method for using an exemplarythrombus removal system to remove a thrombus, according to an embodimentof the present disclosure;

FIG. 7A shows a balloon catheter having two balloons positioned within athrombus within a mammalian vessel, according to an embodiment of thepresent disclosure;

FIG. 7B shows the use of a chemical agent by way of a thrombus removalsystem within a mammalian vessel, according to an embodiment of thepresent disclosure;

FIG. 7C shows the disruption and/or dissolution of at least part of athrombus from the use of a chemical agent by way of a thrombus removalsystem within a mammalian vessel, according to an embodiment of thepresent disclosure;

FIG. 8A shows a balloon catheter having two balloons positioned within athrombus within a mammalian vessel, according to an embodiment of thepresent disclosure;

FIG. 8B shows the use of disruptive oscillations by way of a thrombusremoval system within a mammalian vessel, according to an embodiment ofthe present disclosure;

FIG. 8C shows the disruption of at least part of a thrombus from the useof disruptive oscillations by way of a thrombus removal system within amammalian vessel, according to an embodiment of the present disclosure;

FIG. 9A shows portions of an exemplary thrombus removal systempositioned within a mammalian vessel with partially deflated balloons,according to an embodiment of the present disclosure;

FIG. 9B shows portions of an exemplary thrombus removal systempositioned within a mammalian vessel with fully deflated balloons,according to an embodiment of the present disclosure;

FIG. 10 shows a block diagram of various components of an exemplarythrombus removal system, according to an embodiment of the presentdisclosure; and

FIG. 11 shows steps of an exemplary method for using an exemplarythrombus removal system to remove a thrombus, according to an embodimentof the present disclosure;

FIG. 12 shows a side perspective view of a thrombectomy sheath,according to an embodiment of the present disclosure;

FIG. 13 shows a distal portion of a thrombectomy sheath, according to anembodiment of the present disclosure;

FIG. 14 shows a side view of a first obturator, according to anembodiment of the present disclosure;

FIG. 15 shows a side view of a second obturator, according to anembodiment of the present disclosure;

FIG. 16A shows a distal portion of a second obturator with a fittingring in an open configuration, according to an embodiment of the presentdisclosure;

FIG. 16B shows a distal portion of a second obturator with a fittingring in a closed configuration, according to an embodiment of thepresent disclosure;

FIG. 17 shows a side view of a third obturator, according to anembodiment of the present disclosure;

FIG. 18A and FIG. 18B show side views of ancillary dilators, accordingto embodiments of the present disclosure;

FIGS. 19 and 20 show portions of systems used to remove clots, accordingto embodiments of the present disclosure;

FIG. 21 shows a block component diagram of a system, according to anembodiment of the present disclosure;

FIG. 22 shows portions of a system used to retrieve a detached balloon,according to an embodiment of the present disclosure; and

FIG. 23 shows a side perspective view of a thrombectomy sheath,according to an embodiment of the present disclosure.

Like reference numerals indicate the same or similar parts throughoutthe several figures.

An overview of the features, functions and/or configuration of thecomponents depicted in the various figures will now be presented. Itshould be appreciated that not all of the features of the components ofthe figures are necessarily described. Some of these non-discussedfeatures, such as various couplers, etc., as well as discussed featuresare inherent from the figures. Other non discussed features may beinherent in component geometry and/or configuration.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of this disclosure is thereby intended.

An exemplary embodiment of a thrombus removal system of the presentdisclosure is shown in FIGS. 1B-1D. As shown in FIG. 1B, at least partof a thrombus removal system 100 may be used to penetrate a thrombus 150(shown alone within a mammalian vessel 152 in FIG. 1A) to facilitateremoval of thrombus 150 from a lumen 154 of mammalian vessel 152. Aguidewire 102, which may or may not be considered part of a thrombusremoval system 100 (depending on the embodiment referenced), may be usedto pierce thrombus 150 so that part of guidewire 102 appears proximalto, within, and distal to, thrombus 150. After piercing thrombus 150,guidewire 102 may be advanced so that a distal end 104 of guidewire 102is distal to thrombus 150 as shown in FIGS. 1B-1D. For purposes ofdepicting use of guidewire 102 and/or other components of thrombusremoval system 100, FIGS. 1A-4C show entry of guidewire 102 and/or othercomponents of thrombus removal system 100 from the left side ofmammalian vessel 152.

After insertion of guidewire 102 through thrombus 150, an umbrellacatheter 110 (an exemplary component/device of a thrombus removal system100 of the present disclosure) may be inserted over guidewire 102 sothat part of umbrella catheter 110 is positioned proximal to, within,and distal to, thrombus 150, as shown in FIG. 1C. In addition, and alsoas shown in FIG. 1C, a balloon catheter 120 (another exemplarycomponent/device of thrombus removal system 100 of the presentdisclosure) may be inserted over umbrella catheter 110 so that part ofballoon catheter 120 (having a balloon 122 coupled to a balloon cathetertube 124) is positioned proximal to, within, and distal to, thrombus150.

After umbrella catheter 110 (and potentially after balloon catheter 120)has/have been positioned, an umbrella 112 of umbrella catheter 110, maybe deployed as shown in FIG. 1D. Deployment of umbrella 112 may beperformed by, for example, retracting part of umbrella catheter 110,which itself comprises an umbrella catheter tube 116, opposite theinitial direction of insertion of umbrella catheter into lumen 154 ofvessel 152 so that umbrella 112 may deploy within lumen 154 of vessel152. For example, a tube 114 of umbrella catheter 110, as shown in FIG.1D, that initially housed some or all of umbrella 112 therein, may beretracted so that umbrella 112 may expand (which may be, for example,autoexpansion to an open configuration from a compressed configurationwithin tube 114). In at least another embodiment, advancement of a shaft116 of umbrella catheter 110, as shown in FIG. 1D, may be performed topush umbrella 112 out of umbrella catheter 110 so that umbrella 112 candeploy within lumen 154 of vessel 152. Umbrella 112, in at least oneembodiment, may comprise a mesh, fabric, or other material capable ofallowing blood and/or other fluids within lumen 152 to passtherethrough, but preventing some or all of thrombus 150 from passingtherethrough as thrombus 150 is disrupted/fractioned from the use of atleast part of an exemplary thrombus removal system 100 of the presentdisclosure. In another embodiment, umbrella 112 may comprise a materialthat substantially or completely prevents any fluid or material withinlumen 154 of vessel 152 from passing therethrough, including portions ofthrombus 150.

After at least part of thrombus removal system 100 has been positionedwithin a vessel 152 (as shown in FIG. 1D), thrombus removal system 100may be used to, for example, chemically and/or physically remove some orall of thrombus 150. In at least one embodiment of a chemical removal ofsome or all of thrombus 150 of the present disclosure, at least part ofthrombus removal system 100 may be positioned within a thrombus 150 at adesired position (as shown in FIG. 1D and described above and asreproduced in FIG. 2A for convenience), whereby thrombus removal system100 may be used to introduce one or more chemical agents 200 (depictedas squares within FIG. 2B) local to thrombus 150. Exemplary chemicalagents 200 capable of disruption and/or dissolution of at least part ofthrombus 150 may include, but are not limited to, one or more tissueplasminogen activators, plasmin, or thrombin, for example. So to avoidundesired exposure of vessel 152 of chemical agents 200 proximal toballoon 122 of balloon catheter 120, balloon 122 may be inflated, asshown in FIG. 2B. In addition, and to avoid undesired exposure of vessel152 of chemical agents 200 and/or portions of thrombus 150 distal toumbrella 112 of umbrella catheter 110, umbrella 112 may be deployed asshown in FIGS. 2A-2C. Deployment of said umbrella 112, as referencedherein, operates to prevent portions of thrombus 150 from entering theblood stream and potentially forming a damaging, and potentially fatal,clot elsewhere in the body. Chemical agents 200 may be introducedthrough one or more apertures 202 defined within balloon catheter 120,so that chemical agents 200 from an agent source (not shown) can beintroduced through a first lumen 204 of balloon catheter 120, out ofaperture(s) 202, and into a lumen 154 of vessel 152. Over time, and asshown in FIG. 2C, chemical agents 200 may disrupt and/or dissolve atleast part of thrombus 150, so that thrombus fragments 250 (depicted ascircles within FIG. 2C) can break away from thrombus 150 and enter intoa second lumen 206 of balloon catheter 120 by way of distal aperture208. Removal of thrombus fragments 250 may occur via suction throughdistal aperture 208 of balloon catheter 120, so that thrombus fragments250 may enter distal aperture 208 as indicated by the arrows shown inFIG. 2C.

In at least one embodiment, and to maintain at least a desired amount offluid local to the treatment area, saline or another biologicallycompatible fluid may be introduced through aperture(s) 202, whereby saidfluid may also help to flush the treatment area so that a desired amountor level of thrombus fragments 250 are removed from the lumen 154 ofmammalian vessel 152.

In at least one embodiment of a physical removal of some or all ofthrombus 150 of the present disclosure, at least part of thrombusremoval system 100 may be positioned within a thrombus 150 at a desiredposition (as shown in FIG. 1D and described above and as reproduced inFIG. 3A for convenience), whereby thrombus removal system 100 may beused to introduce disruptive oscillations 300 therethrough (depicted ascurved lines within FIG. 3B) local to thrombus 150. Disruptiveoscillations 300 may be introduced via ultrasound or one or more othertypes of physical movement (side-to-side, back-and-forth, and/or inanother direction) to increase the shear stress of thrombus 150 todisrupt thrombus 150 and cause portions of thrombus 150 to break away.So to avoid undesired exposure of vessel 152 proximal to balloon 122 ofballoon catheter 120 to thrombus fragments 250, balloon 122 may beinflated, as shown in FIG. 3B. In addition, and to avoid undesiredexposure of vessel 152 to portions of thrombus 150 distal to umbrella112 of umbrella catheter 110, umbrella 112 may be deployed as shown inFIGS. 3A-3C. Over time, and as shown in FIG. 3C, disruptive oscillations300 may disrupt thrombus 150, so that thrombus fragments 250 (depictedas circles within FIG. 3C) can break away from thrombus 150 and enterinto a second lumen 206 of balloon catheter 120 by way of distalaperture 208. Removal of thrombus fragments 250 may occur via suctionthrough distal aperture 208 of balloon catheter 120, so that thrombusfragments 250 may enter distal aperture 208 as indicated by the arrowsshown in FIG. 3C. In at least one embodiment, and to maintain at least adesired amount of fluid local to the treatment area, saline or anotherbiologically compatible fluid may be introduced through aperture(s) 202,whereby said fluid may also help to flush the treatment area so that adesired amount or level of thrombus fragments 250 are removed from thelumen 154 of mammalian vessel 152.

Removal of a thrombus removal system 100 of the present disclosure froma lumen 154 of a vessel 152 is shown in FIGS. 4A-4C. As shown in FIGS.4A and 4B, balloon 122 is deflated (shown as partially deflated in FIG.4A and completely deflated in FIG. 4B) to unsecure thrombus removalsystem 100 from vessel 152. Pull-back of one or more components ofthrombus removal system 100 then causes the deployed umbrella 112 toinvert (as shown in the change of orientation from FIG. 4A to FIG. 4B),and further pulling of umbrella catheter 110 back causes umbrella 112 tofit at least partially within distal aperture 208 to facilitate removalof thrombus removal system 100 from the lumen 154 of mammalian vessel152.

FIG. 5 shows a block diagram of various components of an exemplarythrombus removal system 100 of the present disclosure. As shown in FIG.5, an exemplary thrombus removal system 100 of the present disclosuremay comprise a guidewire 102, an umbrella catheter 110 comprising anumbrella 112 and an umbrella catheter tube 114, and a balloon catheter120 comprising a balloon 122 and a balloon catheter tube 124. Ballooncatheter 120 may define a first lumen 204 therethrough, whereby one ormore chemicals and/or a fluid from a substance source 500 can beprovided from substance source 500, through the first lumen 204, throughone or more apertures 202 defined within balloon catheter tube 124, andinto a lumen 154 of a mammalian vessel 152. Balloon catheter 120 mayalso define a second lumen 206 therethrough, whereby suction from asuction source 502 may be provided through second lumen 206 into lumen154 of mammalian vessel 152 to remove fluid and/or particulates throughdistal aperture 208. Balloon catheter 120 may further define a thirdlumen 504 therethrough, whereby an inflation/deflation source 506 incommunication therewith is operable to inflate and/or deflate balloon122 that is also in communication with third lumen 504. Further, and inat least one embodiment, an oscillator 508 (such as an ultrasoundapparatus) may be in communication with one or more components ofballoon catheter 120 to introduce disruptive oscillations into a lumen154 of a mammalian vessel 152.

As generally referenced above and as shown in the method step diagram ofFIG. 6, an exemplary embodiment of a method of removing a thrombus froma lumen 154 of a mammalian vessel 152 is provided herein. In at leastone embodiment of a method 600 of the present disclosure, method 600comprises the steps of inserting a guidewire 102 into a lumen 154 of amammalian vessel 152 through a thrombus 150 present therein (anexemplary guidewire insertion step 602), inserting an umbrella catheter110 through the thrombus 150 around at least part of the guidewire 102(an exemplary umbrella catheter insertion step 604), and inserting aballoon catheter 120 through the thrombus 150 around at least part ofthe umbrella catheter 110 (an exemplary balloon catheter insertion step606). An exemplary method 600 of the present disclosure furthercomprises the steps of deploying an umbrella 112 of the umbrellacatheter 110 to at least substantially occlude the lumen 154 of themammalian vessel 152 distal to the thrombus 150 or to at leastsubstantially prevent a portion of the thrombus 150 from passing throughthe umbrella 112 (an exemplary umbrella deployment step 608), inflatinga balloon 122 of the balloon catheter 120 to at least substantiallyocclude the lumen 154 of the mammalian vessel 152 proximal to thethrombus 150 (an exemplary balloon inflation step 610), operating one ormore of the umbrella catheter 110 and/or the balloon catheter 120 todisrupt and/or dissolve the thrombus 150 (an exemplary operation step612), and applying suction through the balloon catheter 120 to remove atleast part of the disrupted thrombus 150 from the lumen 154 of themammalian vessel 152 (an exemplary thrombus removal step 614).

In at least one embodiment of method 600 of the present disclosure,operation step 612 comprises operating the balloon catheter 120 tointroduce one or more chemical agents 200 through the balloon catheter120 into the lumen 154 of the mammalian vessel 152 to disrupt and/ordissolve the thrombus 150. In at least another embodiment, operationstep 612 comprises operating one or more of the umbrella catheter 110and/or the balloon catheter 120 to introduce one or more disruptiveoscillations therethrough to disrupt the thrombus 150.

In at least one embodiment of a method 600 of the present disclosure,method 600 further comprises the steps of deflating the balloon 122 (anexemplary balloon deflation step 616) and inverting the umbrella 112 (anexemplary umbrella inversion step 618) so that the umbrella 112 can bepositioned at least partially within a distal aperture 208 of theballoon catheter 120, and removing the guidewire 102, the umbrellacatheter 110, and the balloon catheter 120 from the lumen 154 of themammalian vessel 152 (an exemplary system removal step 620).

At least another embodiment of a thrombus removal system 100 of thepresent disclosure is shown in FIGS. 7A-7C. As shown in FIG. 7A, aguidewire 102 is positioned through a thrombus 150, and a ballooncatheter 120 is positioned around at least part of guidewire 102. Asshown in FIG. 7A, balloon catheter 120 comprises a first balloon 122positioned along balloon catheter 120 proximal to thrombus 150, andfurther comprises a second balloon 700 positioned along balloon catheter120 distal to thrombus 150. In such an embodiment, balloon catheter 120may define a lumen 504 in communication with an inflation/deflationsource 506, whereby lumen 504 is in communication with first balloon 122and second balloon 700 to inflate and/or deflate said balloons 122, 700.In at least another embodiment, an additional lumen 702 may be definedwithin balloon catheter 120, whereby lumen 504 is in communication withfirst balloon 122 and the additional lumen 702 is in communication withsecond balloon 700, so that an inflation/deflation source 506 incommunication with lumens 504, 702 may inflate and/or deflate balloons122, 700 separately.

In at least another embodiment of a chemical removal of some or all ofthrombus 150 of the present disclosure, at least part of thrombusremoval system 100 may be positioned within a thrombus 150 at a desiredposition (as shown in FIG. 7A), whereby thrombus removal system 100 maybe used to introduce one or more chemical agents 200 capable ofdisruption and/or dissolution of at least part of thrombus 150 (depictedas squares within FIG. 7B) local to thrombus 150. So to avoid undesiredexposure of vessel 152 of chemical agents 200 proximal to first balloon122 of balloon catheter 120, first balloon 122 may be inflated, as shownin FIGS. 7B and 7C. In addition, and to avoid undesired exposure ofvessel 152 of chemical agents 200 and/or portions of thrombus 150 distalto second balloon 700, second balloon 700 may also be inflated, as shownin FIGS. 7B and 7C. Chemical agents 200 may be introduced through one ormore apertures 202 defined within balloon catheter 120, so that chemicalagents 200 from an agent source (not shown) can be introduced through alumen 204 of balloon catheter 120, out of aperture(s) 202, and into alumen 154 of vessel 152. Over time, and as shown in FIG. 7C, chemicalagents 200 may disrupt and/or dissolve at least part of thrombus 150, sothat thrombus fragments 250 (depicted as circles within FIG. 7C) canbreak away from thrombus 150 and enter into a second lumen 206 ofballoon catheter 120 by way of aperture 208. Removal of thrombusfragments 250 may occur via suction through aperture 208 of ballooncatheter 120, so that thrombus fragments 250 may enter aperture 208 asindicated by the arrows shown in FIG. 7C.

As generally referenced herein, an “occlusion element” may refer to aballoon catheter 120 with one or more balloons 122, 700, or may refer toan umbrella catheter 110 with one or more umbrellas 112. For example, anexemplary embodiment of a thrombus removal system 100 of the presentdisclosure may comprise a balloon catheter 120 with a first balloon 122and an occlusion element, with the occlusion element being either anumbrella catheter 110 with one or more umbrellas 112 (as shown in FIGS.2B and 2C, for example), or a balloon catheter 120 with a second balloon700 (as shown in FIGS. 7B and 7C, for example).

In at least another embodiment of a physical removal of some or all ofthrombus 150 of the present disclosure, at least part of thrombusremoval system 100 may be positioned within a thrombus 150 at a desiredposition (as shown in FIG. 8A), whereby thrombus removal system 100 maybe used to introduce disruptive oscillations 300 therethrough (depictedas curved lines within FIG. 8B) local to thrombus 150. Disruptiveoscillations 300 may be introduced via ultrasound or one or more othertypes of physical movement (side-to-side, back-and-forth, and/or inanother direction) to increase the shear stress of thrombus 150 todisrupt thrombus 150 and cause portions of thrombus 150 to break away.So to avoid undesired exposure of vessel 152 proximal to first balloon122 of balloon catheter 120 to thrombus fragments 250, first balloon 122may be inflated, as shown in FIGS. 8B and 8C. In addition, and to avoidundesired exposure of vessel 152 to portions of thrombus 150 distal tosecond balloon 700, second balloon 700 may also be inflated, as shown inFIGS. 8B and 8C. Over time, and as shown in FIG. 8C, disruptiveoscillations 300 may disrupt thrombus 150, so that thrombus fragments250 (depicted as circles within FIG. 8C) can break away from thrombus150 and enter into a second lumen 206 of balloon catheter 120 by way ofaperture 208. Removal of thrombus fragments 250 may occur via suctionthrough aperture 208 of balloon catheter 120, so that thrombus fragments250 may enter aperture 208 as indicated by the arrows shown in FIG. 8C.In at least one embodiment, and to maintain at least a desired amount offluid local to the treatment area, saline or another biologicallycompatible fluid may be introduced through aperture(s) 202, whereby saidfluid may also help to flush the treatment area so that a desired amountor level of thrombus fragments 250 are removed from the lumen 154 ofmammalian vessel 152.

Removal of an exemplary thrombus removal system 100 of the presentdisclosure from a lumen 154 of a vessel 152 is shown in FIGS. 9A and 9B.As shown in FIGS. 9A and 9B, balloons 122, 700 are deflated (shown aspartially deflated in FIG. 9A and completely deflated in FIG. 9B) tounsecure thrombus removal system 100 from vessel 152 to facilitateremoval of thrombus removal system 100 from the lumen 154 of mammalianvessel 152.

FIG. 10 shows a block diagram of various components of another exemplarythrombus removal system 100 of the present disclosure. As shown in FIG.10, an exemplary thrombus removal system 100 of the present disclosuremay comprise a guidewire 102 and a balloon catheter 120 comprising afirst balloon 122, a second balloon 700, and a balloon catheter tube124. Balloon catheter 120 may define a first lumen 204 therethrough,whereby one or more chemicals and/or a fluid from a substance source 500can be provided from substance source 500, through the first lumen 204,through one or more apertures 202 defined within balloon catheter tube124, and into a lumen 154 of a mammalian vessel 152. Balloon catheter120 may also define a second lumen 206 therethrough, whereby suctionfrom a suction source 502 may be provided through second lumen 206 intolumen 154 of mammalian vessel 152 to remove fluid and/or particulatesthrough distal aperture 208. Balloon catheter 120 may further define athird lumen 504 therethrough, whereby an inflation/deflation source 506in communication therewith is operable to inflate and/or deflate firstballoon 122 that is also in communication with third lumen 504. Ballooncatheter 120 may further define a fourth lumen 702 therethrough, wherebyan inflation/deflation source 506 in communication therewith is operableto inflate and/or deflate second balloon 700 that is also incommunication with fourth lumen 702. Further, and in at least oneembodiment, an oscillator 508 (such as an ultrasound apparatus) may bein communication with one or more components of balloon catheter 120 tointroduce disruptive oscillations into a lumen 154 of a mammalian vessel152.

As generally referenced above and as shown in the method step diagram ofFIG. 11, another exemplary embodiment of a method of removing a thrombusfrom a lumen 154 of a mammalian vessel 152 is provided herein. In atleast one embodiment of a method 600 of the present disclosure, method600 comprises an exemplary guidewire insertion step 602, an exemplaryballoon catheter insertion step 606, and the step of inflating balloons122, 700 of the balloon catheter 120 to at least substantially occludethe lumen 154 of the mammalian vessel 152 proximal and distal to thethrombus 150 (another exemplary balloon inflation step 610). In at leastone embodiment of method 600 of the present disclosure, method 600further comprises operating the balloon catheter 120 to disrupt and/ordissolve the thrombus 150 (another exemplary operation step 612) and anexemplary thrombus removal step 614.

In at least one embodiment of method 600 of the present disclosure,operation step 612 comprises operating the balloon catheter 120 tointroduce one or more chemical agents 200 through the balloon catheter120 into the lumen 154 of the mammalian vessel 152 to disrupt and/ordissolve the thrombus 150. In at least another embodiment, operationstep 612 comprises operating the balloon catheter 120 to introduce oneor more disruptive oscillations therethrough to disrupt the thrombus150.

In at least one embodiment of a method 600 of the present disclosure,method 600 further comprises the steps of deflating balloons 122, 700(another exemplary balloon deflation step 616) and removing theguidewire 102 and the balloon catheter 120 from the lumen 154 of themammalian vessel 152 (another exemplary system removal step 620).

The present disclosure includes disclosure of additional thrombusremoval systems 100. In at least one embodiment, an exemplary thrombusremoval system 100 of the present disclosure, as shown in FIG. 12,comprises a thrombectomy sheath 1200 configured as an elongated tubehaving a circumferential outer wall 1202 reinforced with a reinforcement1204, such as a wire reinforcement or other reinforcement known ordeveloped in the art, whereby reinforcement 1204 comprises a differentmaterial than circumferential outer wall 1202. For example, and in atleast one embodiment, circumferential outer wall 1202 comprises aflexible polymer material, while reinforcement 1204 comprises a metallicmaterial. In various embodiments, circumferential outer wall 1202 isvery thin, utilizing reinforcement 1204 to prevent collapse or kinkingat various bending points of thrombectomy sheath 1200 during use.

As shown in FIG. 12, exemplary thrombectomy sheaths 1200 of the presentdisclosure may comprise a sonovisible element 1210 at or near a distalend 1212 of thrombectomy sheath 1200. Sonovisible element 1210 may beconfigured as a ring (as shown in FIG. 12), or comprise a differentconfiguration, such as one or more non-circumferential elements 1210positioned along or within circumferential outer wall 1202 at or neardistal end 1212 of thrombectomy sheath 1200. Sonovisible element 1210 isreadily visible within a mammalian vessel 152 when detected from outsidea patient using ultrasound and/or fluoroscopy, so that the position ofdistal end 1212 of thrombectomy sheath 1200 relative to, for example, apuncture site of a vein and/or within the vein, can be located byultrasound and/or fluoroscopy.

Furthermore, thrombectomy sheaths 1200 of the present disclosure mayself-expand (be auto-expandable) so to easier insert the same viavenipuncture. In various embodiments, reinforcements 1204 may comprise ametal, nitinol, and/or another material suitable to permitauto-expansion as desired.

Thrombectomy sheaths 1200 of the present disclosure having a relativelylarge bore, such as having external diameters (measured from an outsideof circumferential outer wall 1202, shown as “D” in FIG. 12) of 10 mm,12 mm, 14 mm, 16 mm, 18 mm, or smaller or larger. In variousembodiments, circumferential outer wall 1202 has a 10 mm or a 12 mmdiameter and a 25 cm length (from distal end 1212 to proximal end 1214),and in other embodiments, circumferential outer wall 1202 has a 14 mm,16 mm, or a 18 mm diameter and a 30 cm length (from distal end 1212 toproximal end 1214). The aforementioned sizes/configurations are intendedfor use, for example, in the popliteal, femoral, or common femoral veinsaccording to the correct fit, noting that an optimal size for aparticular patient may be determined by, for example, sizing the vein ofentry by ultrasound measurement or other means. Other configurations(diameters and lengths) of thrombectomy sheaths 1200 are also within thescope of the present disclosure.

It is noted that in various thrombectomy sheath 1200 embodiments of thepresent disclosure, a balloon near distal end 1212 of circumferentialouter wall 1202 is not used, for simplicity of construction and alsobecause the correct fit of a thrombectomy sheath 1200 to a particularpatient would likely prevent any undesired back-bleeding from below theentry site seeping around the thrombectomy sheath 1200. In embodimentsof thrombectomy devices 1200 of the present disclosure having a balloon1300, such as shown in FIG. 13, at least part of balloon 1300 may bepositioned at or near distal end 1212 within an indention 1302 definedwithin circumferential outer wall 1202, so to keep a generallyconsistent and smooth outer profile of thrombectomy sheath 1200. In suchan embodiment, balloon 1300 may be inflated using an inflation/deflationsource 506 (not shown in FIG. 13) connected to an inflation/deflationport 1304 of an inflation/deflation channel 1306 extending from balloon1300 to a location at or near proximal end 1214 of thrombectomy sheath1200.

Thrombectomy sheaths 1200, in various embodiments, have no valves at ornear proximal end 1214, as back-bleeding can be readily controlled byelevating proximal end 1214 above the low venous pressure (when distalend 1212 is positioned within a vein), using a finger, for example, toclose proximal end aperture 1222, as shown in FIG. 12, which is oppositedistal end aperture 1220 of thrombectomy sheath 1200.

Exemplary systems 100 of the present disclosure may also comprise one ormore obturators, as provided in further detail below. In at least onesystem 100 embodiment, system 100 comprises three obturators havingdifferent configurations. A first obturator 1400 may be used for initialintroduction, and a second obturator 1500 may be used after a largevenipuncture has already been made by or in connection with the initialintroduction of part of thrombectomy sheath 1200 into a vein. A thirdobturator 1700 is used to insert, for example, commercially availablebiodegradable biostatic sponges over the venipuncture at the end of theprocedure. Various obturators 1400, 1500, 1700 of the present disclosuremay comprise a soft flexible polymer and/or rubber materials that wouldconform to a curvature of thrombectomy sheath 1200 once part ofthrombectomy sheath 1200 is positioned within a vein.

FIG. 14 shows an exemplary first obturator 1400 of the presentdisclosure. As shown in FIG. 14, first obturator 1400 is configured tofit within a lumen 1250 defined within thrombectomy sheath 1200, so thatfirst obturator 1400 fits snugly therein. First obturator 1400 maycomprise a flange 1402, which may be configured as a beveled ring orother configuration having a larger cross-section than a generaldiameter of the elongated portion 1404 of first obturator 1400, which isconfigured to engage or couple to (such as to snap in or otherwise mateto) a proximal coupler 1260 of thrombectomy sheath 1200. A taperedportion 1406 at a distal end 1408 of first obturator 1400 allows forrelatively smooth introduction of distal end 1408 into a vein (anexemplary mammalian vessel 152) as it is advanced over a guidewire 102(not shown in FIG. 14) so to dilate the vein. In at least oneembodiment, tapered portion 1406 projects 7 cm or more or less beyondthrombectomy sheath 1200. A guidewire channel 1410 is defined along alength of first obturator, ending with a distal end aperture 1412, andconfigured to receive a guidewire 102 having various diameters, such asup to 0.035″ or more.

An exemplary second obturator 1500 of the present disclosure is shown inFIG. 15. Second obturators 1500 of the present disclosure are generallyshorter than first obturators 1400 of the same system 100, projecting 3cm (or more or less in various embodiments) beyond distal end 1212 ofthrombectomy sheath 1200 when positioned therein. As shown in FIG. 15,second obturators 1500 have a rapid taper 1502 near a distal end 1504 ofsecond obturator 1500, terminating at a smoothed tip 1506. Secondobturator 1500, as shown in FIG. 15, comprises an elongated portion 1510extending from a flange 1512 (an effective handle for a user of secondobturator 1500) to a cylindrical portion 1520, which can be 4 cm inlength (or longer or shorter), configured for a relatively snug fit whenpositioned within lumen 1250 of thrombectomy sheath, and whereby distalend 1504 of second obturator extends at or about 3 cm (or more or less)from distal end 1212 of thrombectomy sheath. Distal end 1504 of secondobturator 1500 terminates at a distal end aperture 1508. Cylindricalportion 1520 has a larger diameter or cross-sectional area as comparedto elongated portion 1510, as shown in FIG. 15. A groove 1600 (which maybe hemi-cylindrical) is defined within cylindrical portion 1520, asshown in FIG. 16A, which can occupy half the circumference (or more orless) of lumen 1250 of thrombectomy sheath 1200 when positioned therein,allowing space for guidewires 102, balloon catheters 120, or snares 2102(shown in FIG. 21, for example) to lie beside or within cylindricalportion 1520 unhindered. A hemi-circular fitting ring 1610, as shown inFIGS. 15, 16A, and 16B, fits upon cylindrical portion 1520 and isconfigured to rotate thereon so to effectively lock portions ofguidewires 102, balloon catheters 120, or snares (not shown), etc.,therein as shown in FIG. 16B. Such a fitting ring 1610 (also referred toas a locking sleeve) can snap onto portions of second obturator 1510 toretain the same thereon, leaving space for the aforementioned guidewires102, balloon catheters 120, snares, or other items to exit distal endaperture 1200 of thrombectomy sheath 1200.

Smoothed tip 1506 and cylindrical portion 1520 of second obturator 1500noted above define a central channel 1550, such as shown in FIG. 15,which can be 8 Fr. or larger or smaller in size, such as to accommodatea 6 Fr. balloon catheter 120, for example. Existing guidewires 102,balloon catheters 120, or snares 2102 entering the vein already can beside loaded into central channel 1550 by gently forcing them throughlongitudinal groove 1600 running the entire length of cylindricalportion 1520. If rubber (or material with similar properties) is used,groove 1600 may spontaneously close behind these inserted items,retaining them within central channel 1550. If second obturator 1500 ismade of polymer, for example, a fitting ring 1610 can be used to retainguidewires 102, balloon catheters 120, snares 2102, etc., withincylindrical portion 1520. Once central channel 1550 is loaded withguidewires 102, balloon catheters 120, snares 2102, etc., fitting ring1610 can be twisted/rotated to retain these items within central channel1550, as shown in FIG. 16B. Fitting rings 1610, in various embodiments,can extend from near the tip of the cone (distal end 1504) to a relativetop 1660 of the cylindrical portion 1520.

Regarding reintroduction of a thrombectomy sheath 1200 that is pulledpurposefully or accidentally out of the vein, a second obturator 1500can be used to load one or more guidewires 102, balloon catheters 120,or snares 2102 (still in the vein) through groove 1600 abovethrombectomy sheath 1200. Second obturator 1500 can then be slid intolumen 1250 of thrombectomy sheath 1200, sliding over the loaded itemsand into the vein through the previously made large venipuncture, wherethrombectomy sheath 1200 itself can then follow suit. Second obturator1500 can then be removed, unloading the contents of central channel 1550from groove 1600.

Regarding the introduction of a new or fresh thrombectomy sheath 1200 toremove a large foreign body (such as a burst angioplasty balloon 122that has detached partially from the stem, or various other items withina vessel 152 such as a vein), a relative back end of balloon catheter120 can be cut, removing any applicable balloon 122 inflation and/orirrigation ports. This would result in a smooth catheter end over whichthe existing small sheath can be removed. The relatively largerthrombectomy sheath 1200 with second obturator 1500 can then beintroduced over the catheter (remainder of balloon catheter 120) intothe vein. The relatively large caliber of thrombectomy sheath 1200allows much easier and quicker retrieval of the foreign body than ispossible through smaller sheaths that are typically used for balloonangioplasty or stenting applications. The large thrombectomy sheath 1200can also be used over existing guide wires 102 (of or within firstobturator 1400 and/or second obturator 1500) to snare displaced stents,filters etc.

FIG. 17 shows an exemplary third obturator 1700 of the presentdisclosure. Third obturator 1700, as shown in FIG. 17, comprises agenerally uniform cylinder 1702 with a flat tip 1704 extending 2 cm ormore or less from distal end 1212 of thrombectomy sheath 1200 whenpositioned therein. A handle 1706 positioned at a proximal end 1708 ofthird obturator 1700 can be used as a grip by the user of thirdobturator 1700.

FIGS. 18A and 18B show exemplary ancillary dilators 1800 of the presentdisclosure. Ancillary dilators 1800 can comprise various sizes, such as10 Fr., 14 Fr., 16 Fr., 20 Fr., 24 Fr., 28 Fr. or other larger orsmaller sizes, and may be 10″ or longer or shorter in length. Ancillarydilators 1800 may comprise a similar construction and/or features asexemplary second obtruators 1500 of the present disclosure, comprisingan elongated body 1802 and a relatively larger ovular portion 1810having a pointed tip 1820 (in various embodiments), defining a groove1600 therein that can be side loaded (as noted above in connection withsecond obturator 1500 embodiments), whereby groove 1600 is eitherself-closing (where portions of ancillary dilators 1800 comprise rubberor a similar material) or by using a fitting ring 1610 also referred toas a locking sleeve, and such as used with polymer-based ancillarydilators 1800),) to retain guidewires 102, balloon catheters 120, etc.,within said groove 1600. Various ancillary dilators can have an ovularportion 1810 approximately 2 cm in length (or longer or shorter), with a2 cm long (or longer or shorter) groove 1600, whereby part of groove1600 defines and/or terminates at a central channel 1550. Ancillarydilators, such as shown in FIGS. 18A and 18B, can have a more gentle(gentler) tapered portion 1860 as compared to blunt taper 1502 of anexemplary second obturator, such as shown in FIG. 15. While cylindricalportion 1520 is convenient when used within thrombectomy sheath 1200, itcan potentially snag into the tissues during withdrawal when used aloneas a dilator. As such, using one or more ancillary dilators 1800 willnot snag due to the smooth taper 1860 of ovular portion 1810.

Ancillary dilators 1800 are useful to dilate a small venipunctureopening, such as when a smaller sheath had been used initially. Thisallows successful introduction of a thrombectomy sheath 1200 forthrombus 150 and/or other foreign body removal.

FIGS. 19 and 20 show use of an exemplary thrombectomy sheath 1200 andpotentially other system 100 components within a vein in attempt toclear a thrombus 150 therefrom. As shown in FIGS. 19 and 20, one or morethrombectomy balloons (exemplary balloons 122 of the present disclosure)may be used, such as Fogarty balloons, are semi-compliant that can bethreaded over a guidewire 102, such as a 0.035″ guidewire 102. Ballooncatheter 120 shaft and/or balloon 122 can comprise a material withhydrophilic coating that slides easily inside the end loading and sideloading obturators 1400, 1500, described above. Radio-opaque markerrings 2150, such as shown in FIGS. 19 and 22, identify the tip and upperand lower ends of the balloon 120.

Use of an exemplary system 100 comprising a thrombectomy sheath 1200 ofthe present disclosure for percutaneous thrombectomy is as follows. Aswill be discussed in detail, the present disclosure uses a large borethrombectomy sheath 1200 and extraction of a clot (thrombus) using oneor more balloons 122. Balloons 122, such as 6 Fr. or 8 Fr. Fogartyballoons, can be used with it withdrawing large amounts of thrombus 150.Balloon 122 is likely to result in less injury to red cells in thecirculation than with thrombus 150 pulverizing devices (less potentialred cell damage and hemoglobinuria). No saline injection is necessarywhen performing such a method.

Systems 100 can also be used to retrieve foreign bodies such aspartially or fully inflated balloons 122, and misplaced stents, filters1900, etc., more easily than with existing devices used in the medicalarts. Use of thrombectomy sheaths 1200 of the present disclosure, asgenerally referenced herein, allows for a closed percutaneous procedurefor thrombectomy.

As shown in FIG. 19, an initial temporary inferior vena cava (IVC)filter 1900 can be inserted well above thrombus 150 through a preferredaccess site (contralateral or the same site to be used for thrombectomy,or via the internal jugular vein, for example). Filter 1900 can then beremoved at the end of the procedure or later as desired.

Ipsilateral, popliteal, femoral, or common femoral vein access isobtained as indicated by the extent of thrombus 150. An initial sheath(not shown in FIG. 19), which may be 11 Fr. or larger or smaller, isinitially introduced over a guidewire 102 (such as a 0.035″ hydrophiliccoated guidewire, for example) to perform a venogram to assess thelocation and extent of thrombus 150. A thrombectomy sheath 1200 (whichmay be properly sized by ultrasound measurement of the accessed vein) isthen introduced over the guide wire 102 using a first obturator 1400 ina single pass or after passage of serial ancillary dilators 1800 asreferenced above.

First obturator 1400 is removed, and back-bleeding through thrombectomysheath, if any, is controlled by elevating the proximal end 1214 ofthrombectomy sheath 1400 above venous pressure and/or plugging proximalend aperture 1222 with a finger beside guidewire 102 or Fogarty catheter(an exemplary balloon catheter 120 having a Fogarty balloon (anexemplary balloon 122 of the present disclosure). Blood from below theinsertion site seeping around thrombectomy sheath 1200, if any, can becontrolled by a sterile occlusive pneumatic cuff (not shown) placedaround the limb immediately below the entry site of thrombectomycatheter 1200.

A 6 or 8 Fr. specially coated Fogarty catheter (an exemplary ballooncatheter 120) can then be introduced and advanced, with the Fogartyballoon (an exemplary balloon 122) inflated above the clot (thrombus150). An inflating syringe (an exemplary inflation/deflation source 506as referenced herein) connected to balloon catheter 120 can behand-controlled, allowing a sense of pressure to be felt within balloon120 as it is withdrawn over varying lumen sizes. Balloon 122 can befurther inflated or deflated as dictated by the “feel” of balloon 122 asit is withdrawn, noting that open thrombectomy using a Fogarty balloon122 may have a similar technique. FIG. 19 shows use of a thrombectomysheath 1200, balloon catheter 120 (having balloon 122), within a lumen154 of a vein (vessel 152), as noted herein. Thrombus 150 can then bewithdrawn into thrombectomy sheath 1200 and pulled out the back end viaproximal end aperture 1222. Multiple back and forth passes (such as 2 or3 or more) of balloon catheter 120 may be required until no furtherthrombus is retrieved, which can generally be achieved by advancing adistal part of balloon catheter 120 with a deflated balloon 122 into andthrough thrombus 150, inflating balloon 122, pulling balloon catheter120 back toward thrombectomy sheath 1200, deflating balloon 122, andrepeating the process as often as desired. Back bleeding after removalof thrombus 150 can be digitally controlled as described herein, or byballoon tamponade, for example, with the Fogarty balloon (balloon 122).If thrombectomy sheath had been inserted below the lower extent ofthrombus 150, for example, the procedure may be complete afterperforming a completion IVUS or venogram through an irrigation catheter(not shown) inserted into the thrombectomy sheath 1200. Thrombectomysheath 1200 can now be pulled back just outside the venipuncture intothe tissues under ultrasound/fluoroscopy guidance, for example. Ahemostatic plug 2100 (Ivalon, Gelfoam, Surgicell, or similar), such asindicated in FIG. 21, can be inserted into the back end of thrombectomysheath 1200 (such as via proximal end aperture 1222) and pushed towardand out of distal end aperture 1220 using third obturator 1700 having aflat tip 1704 into the tissues immediately overlying the venipuncturesite.

If the thrombectomy sheath 1200 had been inserted into thrombus 150,only the upper portion had been cleared and some will remain in the veinbelow the venipuncture. The following procedure can be used to clearthat residual thrombus 150:

A second hydrophilic coated guide wire (exemplary guide wire 102) is nowpassed up the vein. Thrombectomy sheath 1200 can then be pulled backjust enough to exit the venipuncture site and lie immediately outside inthe tissues. This can be performed with the aid of ultrasound andfluoroscopy monitoring the position of the locator ring (sonovisibleelement 1210) at or near the distal end 1212 of thrombectomy sheath1200. Ultrasound imaging would show, for example, the vein (vessel 152)dropping back from thrombectomy sheath 1200 as it exits thevenipuncture. A first Fogarty catheter (balloon catheter 12, identifiedas 120 a in FIG. 20) can be positioned 3 cm (or further or nearer) abovethe venipuncture (with fluoroscopy aid) and can be left with a firstballoon 122 (identified as 122 a in FIG. 20) inflated to control backbleeding from segments of vein (vessel 152) above the venipuncturecleared of thrombus 150.

A second standard 5 Fr Fogarty catheter (another exemplary ballooncatheter 120, identified as 120 b in FIG. 20) can be threaded over thesecond guide wire 102 and be positioned with a second balloon 122(identified as 122 b in FIG. 20) inflated just below the first speciallycoated Fogarty balloon 122 a left inflated to control back bleeding,such as shown in FIG. 20. The inflated parked balloon 122 a alsoprevents the lower thrombus 150 from travelling up the vein as it isextracted. A bandage (such as an Esmarch bandage, not shown) can betightly applied starting at the foot level and wound around the leg upto the point of the skin entry of thrombectomy sheath 1200, for example.Elevation of the leg can also help this process. The Esmarch bandage cansqueeze the residual thrombus 150, exiting the venipuncture. Thrombus150 can be removed through thrombectomy sheath by pulling the inflatedsecond Fogarty balloon (such as a 5 Fr. balloon 120, shown as 122 b inFIG. 20). A hydrophilic coating of the special Fogarty catheter(catheters 120 a and/or 120 b and/or components thereof, such asballoons 122 a and/or 120 b) and the guidewires 102 (asapplicable/desired) allow the second Fogarty balloon (balloon 122 b),for example, to slide easily beside them pushing them to the peripheryof thrombectomy sheath 1200 as thrombus 150 is extracted. Several“passes” of the second balloon 122 b may be required for completethrombus 150 clearance, using the same or a similar process as describedabove in connection with FIG. 19 (advancement, inflation, retraction,deflation, etc.). After all or substantially all extruded thrombus 150is extracted, the parked first coated Fogarty catheter balloon 122 a ispulled down to the venipuncture extracting any remaining thrombus 150trapped in the vein between the Fogarty balloon 122 a and thevenipuncture. The Fogarty catheter 120 a can then be removed. Bleedingthrough the venotomy and thrombectomy sheath 1200 at this stage can becontrolled by compressing the vein by the sheath tip positionedimmediately outside the venotomy. At this point a completion IVUS orvenogram can be performed and the two guidewires 102 in the vein can beremoved. Next, thrombectomy sheath can be removed after insertinghemostatic plug 2100, for example, as described above.

The present disclosure also includes disclosure of removing a partiallydetached angioplasty balloon, stent, or other foreign body usingthrombectomy sheath 1200. For example, a guidewire 102, balloon catheter120 stem or loop, etc., in place inside the vein when the mishap hadoccurred should be retained. Typically, a relatively small sheath (10Fr. or smaller, for example) would have been used. This small sheathshould be removed cutting of ports and side arms of the balloon catheter120 to slide the small sheath over the back end. Side loading dilatorscan be optionally used to enlarge the venipuncture site at this point.If only a guide wire 102 is present, a thrombectomy sheath (such as thelargest allowable for the vein; 2 mm oversizing of thrombectomy sheath1200 can be well tolerated) with a first obturator 1400 can be used tointroduce thrombectomy sheath 1200 in a single pass. If larger ballooncatheters 120 or snares 2102 are present, a second obturator 1500 couldbe used side-loading it as described above. Partially detached (usuallyat the lower end) balloons 122, even if the balloon 122 had ‘bunched up’due to invagination or eversion (‘parachuted’) can be retrieved throughthe large thrombectomy sheath 1200 by pulling on the balloon catheter120 stem. If the balloon 122 is completely detached, such as shown inFIG. 22, it can be easily retrieved by a loop 2104 of snare 2102 throughthe large lumen thrombectomy sheath 1200. Many types of misplaced stentsand filters 1900 can also be retrieved with standard techniques throughthe large thrombectomy sheath 1200.

Thrombectomy sheaths 1200 of the present disclosure, as describedherein, are relatively simple devices and are expected to perform wellclinically as established techniques are used. FIG. 21 shows a blockcomponent diagram of exemplary components of a system 100 of the presentdisclosure, noting that any number of system 100 embodiments may includeone or more of the various components shown therein and/or otherwisedescribed herein.

An additional thrombectomy sheath 1200 embodiment is shown in FIG. 23.As shown in FIG. 23, thrombectomy sheath 1200 comprises a flared distalend 1212 comprising a flared portion 2300 having a cross-section largerthan that of circumferential outer wall 1202 proximal to flared portion2300. Such a configuration permits a larger thrombus 150 to enter lumen1250 of thrombectomy sheath 1200 than may otherwise be possible withoutflared portion 2300. Various thrombectomy sheaths 1200 of the presentdisclosure may further comprise a fragmenter 2310, such as one or moreblades, spines, etc., configured to at least partially fragment thrombus150 as it passes through thrombectomy sheath 1200 for ease of potentialextraction therefrom.

Various thrombus removal systems 100 of the present disclosure maycomprise components known in the catheter arts, such asbiologically-compatible plastics, rubber, stainless steel, and the like.

While various embodiments of thrombus removal systems and devices andmethods of using the same have been described in considerable detailherein, the embodiments are merely offered by way of non-limitingexamples of the disclosure described herein. It will therefore beunderstood that various changes and modifications may be made, andequivalents may be substituted for elements thereof, without departingfrom the scope of the disclosure. Indeed, this disclosure is notintended to be exhaustive or to limit the scope of the disclosure.

Further, in describing representative embodiments, the disclosure mayhave presented a method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described.Other sequences of steps may be possible. Therefore, the particularorder of the steps disclosed herein should not be construed aslimitations of the present disclosure. In addition, disclosure directedto a method and/or process should not be limited to the performance oftheir steps in the order written. Such sequences may be varied and stillremain within the scope of the present disclosure.

The invention claimed is:
 1. A thrombectomy system, comprising: athrombectomy sheath, comprising: a circumferential outer wall reinforcedwith a reinforcement, configured as an elongated tube having a lumentherethrough; and a sonovisible element positioned at or near a distalend of the circumferential outer wall; wherein the thrombectomy sheathis sized and shaped to be at least partially positioned within a veinproximal to a thrombus or other item within the vein and furtherconfigured to expand to contact the vein to secure the thrombectomysheath within the vein; and wherein the lumen is sized and shaped toreceive a device selected from the group consisting of a ballooncatheter and a snare having a loop; and an elongate body comprising adistal end and a longitudinal groove on said distal end; wherein theelongate body comprises a second obturator comprising an elongatedportion and the distal end comprises a cylindrical portion having alarger diameter than the elongated portion, the cylindrical portioncomprising the longitudinal groove which is a hemi-cylindrical groovedefined therein configured to receive at least part of the ballooncatheter, and further comprising a fitting ring configured to fit uponthe cylindrical portion and rotate thereon so to lock at least part ofthe balloon catheter within the hemi-cylindrical groove.
 2. Thethrombectomy system of claim 1, wherein the circumferential outer wallcomprises a flexible polymer material, and wherein the reinforcementcomprises a metallic material.
 3. The thrombectomy system of claim 1,wherein the circumferential outer wall is configured for autoexpansion.4. The thrombectomy system of claim 1, further comprising: a balloonpositioned at or near a distal end of the circumferential outer wall, atleast partially positioned within an indention defined within thecircumferential outer wall.
 5. The thrombectomy system of claim 1,further comprising: a first obturator configured to fit within the lumenof the thrombectomy sheath, the first obturator comprising a flangeconfigured to engage a proximal coupler of the thrombectomy sheath anddefining a tapered portion at a distal end, the tapered portionconfigured to extend from the distal end of the thrombectomy sheath soto dilate the vein when advanced therein.
 6. The thrombectomy system ofclaim 5, further comprising: an ancillary dilator comprising anelongated portion and an ovular portion larger than the elongatedportion and having a pointed tip and defining a groove thereinconfigured to receive at least part of a balloon catheter therein, andfurther comprising a fitting ring configured to fit upon the relativelylarger ovular portion and rotate thereon so to lock at least part of theballoon catheter within the groove.
 7. The thrombectomy system of claim5, wherein when a guidewire is positioned within the vein and when thefirst obturator is positioned within the lumen of the thrombectomysheath, advancement of the first obturator and the thrombectomy sheathwithin the vein along the guidewire causes the vein to dilate.
 8. Thethrombectomy system of claim 1, further comprising: a third obturatorcomprising a generally uniform cylinder having a flat tip, the thirdobturator configured to extend at least 2 cm from the distal end of thethrombectomy sheath when positioned therein.
 9. The thrombectomy systemof claim 8, further comprising: a hemostatic plug configured to bepushed through the lumen of the thrombectomy sheath using the flat tipof the third obturator so that the hemostatic plug is positioned withinthe vein after being pushed out of the thrombectomy sheath.
 10. Thethrombectomy system of claim 1, further comprising the balloon catheter.11. The thrombectomy system of claim 1, further comprising the snarehaving a loop, the snare configured to fit within the lumen of thethrombectomy sheath and to engage a thrombus within the vein using theloop.
 12. The thrombectomy system of claim 1, wherein when thethrombectomy sheath is at least partially positioned within the veinproximal to the thrombus, the balloon catheter can be positioned throughthe lumen of the thrombectomy sheath so that a balloon of the ballooncatheter is positioned distal to the thrombus, and whereby inflation ofthe balloon and retraction of the balloon catheter through thethrombectomy sheath removes the thrombus from the vein.
 13. Athrombectomy system, comprising: a thrombectomy sheath, comprising: acircumferential outer wall comprising a flexible polymer materialreinforced with a reinforcement comprising a metallic material,configured as an elongated tube having a lumen therethrough; and asonovisible element positioned at or near a distal end of thecircumferential outer wall; wherein the thrombectomy sheath is sized andshaped to be at least partially positioned within a vein proximal to athrombus or other item within the vein and further configured to expandto contact the vein to secure the thrombectomy sheath within the vein;and wherein the lumen is sized and shaped to receive a device selectedfrom the group consisting of a balloon catheter and a snare having aloop; and an obturator comprising an elongated portion and a distalcylindrical portion having a larger diameter than the elongated portion,the cylindrical portion having a hemi-cylindrical groove defined thereinconfigured to receive at least part of the balloon catheter, and furthercomprising a fitting ring configured to fit upon the cylindrical portionand rotate thereon so to lock at least part of the balloon catheterwithin the hemi-cylindrical groove.
 14. The thrombectomy system of claim13, further comprising: a second obturator configured to fit within thelumen of the thrombectomy sheath, the second obturator comprising aflange configured to engage a proximal coupler of the thrombectomysheath and defining a tapered portion at a distal end, the taperedportion configured to extend from the distal end of the thrombectomysheath so to dilate the vein when advanced therein.
 15. The thrombectomysystem of claim 13, further comprising: an ancillary dilator comprisingan elongated portion and an ovular portion larger than the elongatedportion and having a pointed tip and defining a groove thereinconfigured to receive at least part of a balloon catheter therein, andfurther comprising a fitting ring configured to fit upon the relativelylarger ovular portion and rotate thereon so to lock at least part of theballoon catheter within the groove.
 16. A thrombectomy method,comprising the steps of: positioning a distal end of a thrombectomysheath over a guidewire positioned within a vein, the thrombectomysheath comprising: a circumferential outer wall reinforced with areinforcement, configured as an elongated tube having a lumentherethrough, and a sonovisible element positioned at or near the distalend of the circumferential outer wall, wherein the thrombectomy sheathis sized and shaped to be at least partially positioned within a veinproximal to a thrombus or other item within the vein and furtherconfigured to expand to contact the vein to secure the thrombectomysheath within the vein, and wherein the lumen is sized and shaped toreceive a device selected from the group consisting of a ballooncatheter and a snare having a loop; advancing the thrombectomy sheathhaving an obturator positioned therein along the guidewire so to dilatethe vein at the thrombectomy sheath, the obturator comprising anelongated portion and a distal cylindrical portion having a largerdiameter than the elongated portion, the cylindrical portion having ahemi-cylindrical groove defined therein configured to receive at leastpart of the balloon catheter, and further comprising a fitting ringconfigured to fit upon the cylindrical portion and rotate thereon so tolock at least part of the balloon catheter within the hemi-cylindricalgroove; advancing the device through the lumen of the thrombectomysheath so that a distal element of the device is positioned distal tothe thrombus.
 17. The thrombectomy method of claim 16, wherein thedevice comprises the balloon catheter, and wherein the step of advancingthe device is performed to advance the balloon catheter through thelumen of the thrombectomy sheath so that a balloon of the ballooncatheter is positioned distal to the thrombus; and wherein the methodfurther comprises the steps of: inflating the balloon within the veindistal to the thrombus; and retracting the balloon catheter through thethrombectomy sheath to remove the thrombus from the vein.
 18. Thethrombectomy method of claim 16, wherein the device comprises the snarehaving the loop, and wherein the step of advancing the device isperformed to advance the snare having the loop through the lumen of thethrombectomy sheath so that the loop of the snare is positioned distalto the thrombus; and wherein the method further comprises the step of:retracting the snare through the thrombectomy sheath to remove thethrombus from the vein.
 19. The thrombectomy method of claim 16, furthercomprising the step of: positioning a filter distal to the thrombuswithin the vein, the filter configured to filter blood within the vein.